MELATONIN FORTE- melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypophysis suis, hypothalamus (suis), lithium carbonicum, magnesia carbonica, pineal (suis) spray
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Melatonin 6X, Nadidum 6X, Niacin 6X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X, Hypophysis Suis 8X, Hypothalamus (Suis) 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Pineal (Suis) 8X.

INDICATIONS:

For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

DIRECTIONS:

Three sprays per day. Hold in mouth for two minutes.

INACTIVE INGREDIENTS:

Citric Acid, Demineralized Water, Ethanol 0.32%, Glycerin, Sodium Benzoate.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

MELATONIN FORTE

HOMEOPATHIC

1 FL OZ (30 ml)

Melatonin Forte

MELATONIN FORTE
melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypophysis suis, hypothalamus (suis), lithium carbonicum, magnesia carbonica, pineal (suis) spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0020
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	6 [hp_X] in 1 mL
NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK)	NADIDE	6 [hp_X] in 1 mL
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	6 [hp_X] in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	6 [hp_X] in 1 mL
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6 [hp_X] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	8 [hp_X] in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	8 [hp_X] in 1 mL
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)	LITHIUM CARBONATE	8 [hp_X] in 1 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	8 [hp_X] in 1 mL
SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7)	SUS SCROFA PINEAL GLAND	8 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0020-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/12/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/04/2012

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0020) , api manufacture(43857-0020) , label(43857-0020) , pack(43857-0020)